BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3201616-011 KIT LIFEPAK CR-PLUS 1EA

    MDR report key: 19309750 · Received May 14, 2024

    Report

    Report Number
    1219103-2024-00002
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Report Date
    June 14, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MKJ
    UDI-DI
    00883873824597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW SHOWED ALL ACCEPTANCE CRITERIA INSPECTIONS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. NO SAMPLES WERE RECEIVED FOR THIS CASE, BUT BASED ON THE TYPE OF ISSUE REPORTED, NO SAMPLE IS NEEDED. AN EXACT ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. AWARENESS TRAINING THROUGH A QUALITY ALERT WAS ISSUED. THE NEED FOR FURTHER SCALE VERIFICATION, PROCESS IMPROVEMENTS AND/OR PRODUCT INSPECTION WAS REVIEWED. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEIR CUSTOMER REPORTED THAT THEY RECEIVED A CHARGEPACK KIT WHICH WAS MISSING THE ELECTRODES - ONLY THE BATTERY WAS IN THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548246 3201616-011 KIT LIFEPAK CR-PLUS 1EA AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ CARDINAL HEALTH CHP31021 233322 00883873824597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown